Distal Tibia Plating System - Cambridge Orthopaedics...fixation concept allows the surgeon to...

$Page 1: Distal Tibia Plating System - Cambridge Orthopaedics...fixation concept allows the surgeon to stabilize the fracture either by the use of lag screw techniques through the plate, or$
Anterolateral & Medial

Distal Tibia Locking Plates

Securing optimal fixation through versatile

anatomic locking plate technology

Distal TibiaPlating System

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Contents

Surgeon Design Team

Introduction

Anterolateral Distal Tibia Locking Plate

Anterolateral Plate Specifications

Medial Distal Tibia Locking Plate

Medial Plate Specifications

Staged Open Reduction and Internal Fixation

Surgical Approaches

Internal Fixation of Fibula and Malleolus

Reconstruction of the Tibia

Plate Selection

Plates

Application of the Plates

Screw Insertion

Ordering Information

8

9

10

11

12

13

14

15

17

18

19

20

22

24

31

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A low profile helps minimize discomfort and soft tissue irritation

Contoured plates mimic the anatomy of the distal tibia

Anterolateral plate is available in wide and narrow widths, to suit patient size

Bullet tip minimizes soft tissue disruption during insertion

Plate insertion handle simplifies submuscular application

Low Profile

Anatomically Contoured

The Distal Tibia Locking Plate System

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For distal tibia procedures that often involve complex fractures and minimal tissue coverage, the Distal Tibia Plating system provides both

strength and low-profile advantages. Having one of the slimmest profiles available and uniquely contoured to align with the distal tibia,

these plates may be used successfully to treat even the most challenging cases.

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F.A.S.T. Guides

Facilitate accurate drilling

Pre-loaded and disposable

Save time in the OR since no intraoperative assembly is required

Color coded guides make identification easy: Red guide=Right, Lime guide=Left

F.A.S.T. Tabs

Distal tabs of the Anterolateral Plate easily contour to conform to the bone

Threaded holes in the tabs of the Anterolateral Plate allow screws to lock to the plate,

providing more stability and greater support

Interlocking alignment of distal screws can create a subchondral scaffold for more rigid fixation

Fast, accurate surgeries

F.A.S.T. Guide™ and F.A.S.T. Tab Technologies

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To facilitate surgical procedures even more, our Distal Tibia Plates come pre-loaded with Fixed Angle Screw Targeting Guides-

F.A.S.T. Guides - that direct the trajectory of the drill right into the plate. Additionally, our F.A.S.T. Tabs Technology provides a robust

interlocking construct for bone fragments.

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Choose locking, non-locking, or multi-directional screws according to need

All options available in each construct

Tapered, threaded screws lock into position when tightened to establish a fixed angle construct

for improved fixation or when optimal screw purchase is required

Locking Multi-Directional Screws (MDS) allow for up to 15 degrees of angulation

Non-locking screws can be positioned and used in compression, neutral, and buttress modes

Compression holes for non-locking screws allow up to 3 mm of axial compression

Versatility in construct

Locking, non-locking, and multi-directional

screw options

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Particularly helpful in challenging fracture cases, the interlocking screw construct of the Distal Tibia Plates provides you with both

versatility and strength.

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8

Roy Sanders, M.D.

Chief, Department of Orthopaedics, Tampa General Hospital

Director, Orthopaedic Trauma Services, Florida Orthopaedic Institute

Tampa, Florida

J. Chris Coetzee, M.D.

Orthopedic Foot and Ankle Specialist

Minnesota Sports Medicine and Twin Cities Orthopedics

Adjunct Associate Professor, University of Minnesota

Minneapolis, Minnesota

David Thordarson, M.D.

Professor of Orthopaedics, University of Southern California

Residency Director, University of Southern California Department of Orthopaedics

Los Angeles, California

Michael Wich, M.D.

Deputy Head, Department of Trauma and Orthopaedic Surgery

Unfallkrankenhaus Berlin

Berlin, Germany

Surgeon Design Team

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Introduction

The DePuy Distal Tibia Plating System represents the next

generation in anatomic plate design. It combines the benefits

of low profile titanium plate metallurgy with the advantages of

multiplanar locked screw technology. These features allow the

formation of a three dimensional matrix of fixed and variable

angle screws to create a true subchondral scaffold that can

provide improved fixation in comminuted fractures or

osteoporotic bone.

The DePuy Distal Tibia Plating System features TiMAX™ low

profile, anatomically contoured implants. In distal tibial surgery

where the soft tissue coverage is at risk, these low profile plates

are designed to minimize discomfort and soft tissue irritation

matching the anatomy of the distal tibia, while still having the

strength needed to permit unimpeded healing.

The System features F.A.S.T. Guide and F.A.S.T. Tab technology

to facilitate surgical procedures and save time in the operating

room. F.A.S.T. Guides allow for accurate drilling and placement

of screws. F.A.S.T. Guides come preloaded and do not require

intraoperative assembly, resulting in significant time savings.

F.A.S.T. Tabs are distal versatile tabs with threaded screw holes

to lock small distal articular fragments to the plate. Screws

placed in these locking holes create an intersecting three-

dimensional scaffold to support the distal articular surface.

Additionally, the DePuy Distal Tibia Plating System allows the

use of locking, variable angle, and standard screws. This hybrid

fixation concept allows the surgeon to stabilize the fracture either

by the use of lag screw techniques through the plate, or by

compression plating techniques. Locking screws serve to

provide stability to comminuted, unstable metaphyseal fractures

or in osteopenic bone.

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Anterolateral Distal Tibia Locking Plate

Compression holes in the shaft of the plate

for 3.5 mm and 4.0 mm non-locking screws

Versatile anatomic locking F.A.S.T.

Tabs form an intersecting scaffold to

capture and support distal fragments

3.5 mm multi-directional locking screws

allow for up to 15 degrees of angulation

Proximal bullet tip facilitates submuscular plate insertion

Low profile, anatomically contoured

plate design for less soft tissue irritation

F.A.S.T. Guides

for easy drilling

TiMAX for strength, biocompatibility and enhanced imaging capabilities

Locking Screws

3.5 mm cortical screws

4.0 mm cancellous screws

3.5 mm multi-directional screws

Non- Locking Screws


4.0 mm cancellous screws, full thread

4.0 mm cancellous lag screws

4.0 mm cannulated cancellous lag screws

Threaded holes for locking 3.5 mm, 4.0 mm,

and 3.5 mm multi-directional screws

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Anterolateral Plate Specifications

Anterolateral Plate Wide Narrow

Head Width 39 mm 34 mm

Head Thickness 3 mm 3 mm

Tab Thickness 3 mm 3 mm

Shaft Width 12 mm 12 mm

Shaft Thickness 3 mm 3 mm

Distance between center holes of shaft 14 mm 14 mm

Orientations Left / Right Left / Right

Lengths 6H, 9H, 12H, 15H 6H, 9H, 12H, 15H

3.5 mm Locking Cortical Screw:

• Larger core diameter and shallower thread pitch for improved

bending and shear strength compared to a standard 3.5 mm

cortical screw

• Self tapping tip minimizes the need for pre-tapping and

eases screw insertion

• Tapered screw head helps ensure alignment of the screw

head into the plate hole

• Tapered threaded head minimizes screw back-out

and construct pullout

• T-15 drive

• Available in lengths of 10 – 70 mm

4.0 mm Locking Cancellous Screw:





• Tapered threaded head minimizes screw back-out

and construct pullout

• T-15 drive


3.5 mm Locking Multi-Directional Screw:

• Cobalt-Chrome screw with large core diameter

• Multi-directional capability offers 15 degrees of angulation

• Creates own thread in plate to help provide strong and

stable construct

• Screw head designed to prevent it from going through

the threaded screw hole

• Self tapping tip minimizes the need for pre-tapping

and eases screw insertion

• 2.2 mm square drive


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Medial Distal Tibia Locking Plate

Compression holes in the shaft of the plate for

3.5 mm and 4.0 mm non-locking screws

Distal tab for 3.5 mm and 4.0 mm

non-locking screw conforms to

shape of medial malleolus

Proximal bullet tip facilitates submuscular plate insertion

Low profile, anatomically contoured

plate design for less soft tissue irritation

F.A.S.T. Guides for easy drilling

TiMAX for strength, biocompatibility and enhanced imaging capabilities

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Threaded holes for locking 3.5 mm, 4.0 mm,

and 3.5 mm multi-directional screws

3.5 mm multi-directional locking screws

allow for up to 15 degrees of angulation

Locking Screws


4.0 mm cancellous screws

3.5 mm multi-directional screws

Non- Locking Screws


4.0 mm cancellous screws, full thread

4.0 mm cancellous lag screws

4.0 mm cannulated cancellous lag screws

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Medial Plate Specifications

Medial Plate

Head Width 23 mm

Average Head Thickness 3 mm

Tab Thickness 2 mm

Shaft Width 12 mm

Shaft Thickness 3 mm

Distance between center holes of shaft 14 mm

Orientations Left / Right

Lengths 6H, 9H, 12H, 15H

3.5 mm Locking Cortical Screw:

• Larger core diameter and shallower thread pitch for improved

bending and shear strength compared to a standard 3.5 mm

cortical screw





• Tapered threaded head minimizes screw back-out and

construct pullout

• T-15 drive


4.0 mm Locking Cancellous Screw:





• Tapered threaded head minimizes screw back-out and

construct pullout

• T-15 drive


3.5 mm Locking Multi-Directional Screw:

• Cobalt-Chrome screw with large core diameter

• Multi-directional capability offers 15 degrees of angulation

• Creates own thread in plate to help provide strong and

stable construct

• Screw head designed to prevent it from going through

the threaded screw hole

• Self tapping tip minimizes the need for pre-tapping

and eases screw insertion

• 2.2 mm square drive


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Staged Open Reduction and Internal Fixation

Portable Traction

When planning to treat a distal tibia fracture

surgically using plates, application of a spanning

external fixator should be performed as soon as

possible (Figure 1).

Pin placement distally is dependent on the type

of frame employed. Proximally placed tibial pins

should be away from planned incisions to avoid

pin tracts possibly infecting the surgical site. When

placing frames, the surgeon should verify that the

tibial shaft is in acceptable alignment, as posterior

subluxation of the talus and hindfoot can lead to

pressure necrosis of the anterior skin. Once the

multi-planar frame has been applied, the patient

should undergo a CT scan, with sagittal and

transverse reconstructions.

DePuy’s temporary spanning fixation device is

TempFix®. It is offered with a U-ring (Cat. No. 8081-

09-000 - Left, 8081-10-000 - Right) or without (Cat.

No. 8081-11-000).

After review of the CT scans and plane films, a

determination can be made regarding the correct

surgical approach and plate application. The fibula

should undergo internal fixation after the CT scan

has been performed, in order to determine the

location of the incisions.

Operative Technique

Regardless of the technique used, the patient must

be given intravenous antibiotics immediately prior

to surgery. Although many surgeons do not use

a tourniquet, it is difficult to evaluate the articular

reduction unless visualization is maximized.

An Esmarch bandage can be used to exsanguinate

the limb, and a high thigh tourniquet can be

inflated to 350 mm Hg for 2.5 hours without any

adverse effects.

Figure 1

When planning to treat a distal tibia fracture surgically using plates, application

of a spanning external fixator should be performed as soon as possible.

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Surgical Approaches

Approaches include a straight anterior incision,

a standard medial incision, or the lateral Böhler

approach. When plating the fibula through a

standard lateral approach, the surgeon should

identify the tibial incision first to avoid narrow skin

bridges between the two incisions.

1. The Antero-Medial Approach

Begin at the level of the distal shaft of the tibia, just

lateral to the anterior crest, and continue distally as

far as needed, staying medial to the anterior tibial

tendon. Take the skin together with the subcutaneous

tissue and the periosteum in a full thickness flap

to prevent separation of the medial skin from its

periosteal blood supply. Expose the joint through

major tears in the soft tissue envelope. If needed,

the joint capsule can be incised in line with the

skin incision, to visualize the articular surface. This

approach offers the surgeon an excellent view of

the medial and anterior distal tibia, but visualization

of the lateral tibial articular surface will be limited

(Figure 2).

Figure 2

One of three surgical approaches can be used.

An example of an Antero-Medial approach.

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Surgical Approaches

2. The Standard Anterior Approach

Make an 8 - 10 cm skin incision centered over the

ankle, with most of the incision proximal to the joint.

Distally, the incision stops at the level of the talo-

navicular joint. Find and protect the superficial

peroneal nerve, which crosses the wound from the

lateral side. Incise the extensor retinaculum in line

with the skin incision, and expose the anterior tibial

(AT) and extensor hallucis longus (EHL) tendons.

Locate and protect the anterior tibial artery and

deep peroneal nerve just medial to the EHL tendon

at the level of the joint. Move the neurovascular

bundle laterally along with the EHL; the AT should

be moved medially. This exposes the ankle

capsule. The exposure of the joint should be

through the major tears in the soft tissue envelope.

Excellent visualization of the medial, and anterior

tibial plafond are possible with this approach, but

visualization of the lateral tibial plafond again is

somewhat limited (Figure 3).

3. The Lateral Approach

Start 5 cm proximal to the ankle joint and slightly

medial to Chaput’s tubercle. Continue distally in

a straight line toward the base of the third and

fourth metatarsals. Identify and protect the superficial

peroneal nerve and proceed through the sub-

cutaneous tissue to expose the superior and inferior

extensor retinaculum, and the tendons of the extensor

digitorum longus, peroneus tertius, hallucis brevis,

and the extensor hallucis longus. After dividing the

extensor retinaculum, the tendons of the extensor

digitorum longus and peroneus tertius, the deep

peroneal nerve, and the dorsalis pedis artery are

moved medially. In the distal aspect of the incision,

the muscle belly of the extensor digitorum brevis

can be seen, and, if greater distal exposure is

needed, this can be mobilized. At completion, the

exposure should allow visualization of the entire

anterior face of the distal tibia, with excellent

visualization of the lateral articular surface of the

tibia. It will be impossible to apply a medial plate

from this incision (Figure 4).Figure 4

Lateral approach.

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Figure 3

Standard Anterior approach.

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Internal Fixation of Fibula and Malleolus

Fibula and Posterior Malleolar Reconstruction

The fibular shaft and lateral malleolus should be

reconstructed initially, depending on the tibial

incision planned. If a midline or antero-medial

incision is planned, a straight lateral or postero-

lateral incision can be used. Standard techniques

of fibular plating (Cat. No. 8141-23-0XX) are used

(Figure 5). If an anterolateral approach to the tibia

is employed, a postero-lateral incision can be used

to fix the fibula. Alternately, both tibial and fibular

fixation may be performed through the same

anterolateral incision. Furthermore, if plain films

and CT scan indicate that the posterior malleolus

is “free floating”, then this fragment must be fixed

at the time of fibula fixation so that a stable fragment

exists to reconstruct the articular surface against.

If this is not performed, the joint will be malreduced

at the end of the surgery.

Note: Anterolateral and Medial Plates are not

indicated to treat fibular fractures.

Figure 5

The fibular shaft should be reconstructed initially using standard techniques.

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Reconstruction of the Tibia

Tibial Reconstruction

When reducing a long bone fracture, axial alignment

is the predominant functional requirement.

When reducing an articular fracture, both anatomic

reconstruction of the joint surface, as well as axial

alignment of the shaft is required. While a millimeter

step in the joint will result in mild angular mal-

alignment in the metaphysis, a millimeter offset

in the metaphysis will translate to several

millimeters of joint incongruity. For this reason,

the articular surface should be approached first.

First externally rotate the medial malleolar fragment.

Next, apply ligamentotaxis through distraction using

either an external fixator or a femoral distractor.

In this way, the comminuted central articular surface

can be visualized. Reduce the comminuted fragments

by using the constant postero-lateral fragment

as the key to the articular reduction. Rebuild

the articular surface by using 1.6 mm K-wires

(Cat. No. 14425-6), either with direct reduction

of one fragment to another, or by wedging small

fragments between larger fragments. When the

surface has been reconstructed, the medial

malleolus is reduced and provisionally pinned

(Figure 6).

Once satisfied with the articular reduction, the

metaphysis is evaluated. Impaction fractures

associated with metaphyseal crush require a

cancellous bone graft. Once completed, each

critical K-wire is replaced with an isolated 3.5 mm

cortical, or 4.0 mm cancellous lag screw. The

reconstructed articular block can then be attached

to the meta-diaphyseal shaft using either isolated

lag screws and a neutralization plate, or a plate

alone in compression mode, with or without lag

screws through the plate (Figure 7).

Figure 7

The reconstructed articular block can then be attached

to the meta-diaphyseal shaft.

Figure 6

Reconstruct the articular surface by using 1.6 mm K-wires, either with

direct reduction of one fragment to another, or by wedging small fragments

between larger fragments.

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Plate Selection

Medial plates cannot be applied using a lateral

incision. Similarly lateral plates cannot be applied

through a medial incision. While a midline incision

allows application of a lateral plate, a medial plate

can be applied only with difficulty. Therefore:

• If the fracture is unstable, with lateral comminution,

and anterior metaphyseal crush is evident, a

lateral approach is chosen, and an anterolateral

plate is recommended (Figure 8).

• If the fracture is more comminuted medially,

and lateral joint involvement is minimal, a medial

incision is used and a medial plate is applied

(Figure 9).

• If comminution is both anterior, medial and lateral,

then a midline incision may be best, coupled with

an anterolateral plate (Figure 10).

Figure 8

Figure 9

Figure 10

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Plates

Anterolateral Distal Tibial Plate

(Cat. No. 8162-0X-0XX).

The Anterolateral Distal Tibial Plate is a low profile,

anatomically contoured plate, designed to fit on

the anterolateral aspect of the distal tibia. These

thin plates are designed to minimize discomfort

and soft tissue irritation around the ankle, while still

having the strength needed to achieve rigid fixation

of the distal tibial fracture. All plates come with

F.A.S.T. Guides for accurate drilling and placement

of screws, with locking, lagging, or variable angle

screw options available in the same construct

(Figure 11).

These plates are pre-contoured and need little,

if any, secondary adjustments to their shape.

In addition, wide and narrow widths are available

to accommodate patient size. Wide plates contain

3 F.A.S.T. Tabs, while narrow plates contain

2 F.A.S.T. Tabs.

Contourable F.A.S.T. Tabs with threaded screw

holes are present distally to lock small distal

articular fragments to the plate. These tabs are

adjustable with Plate Tab Benders that fit over the

F.A.S.T. Guides for easy and secure control.

Contouring can be performed before application,

or in situ. Should these tabs not be desired, they

are cleanly removed with a few bending cycles,

without leaving sharp edges. Alternatively, they may

be clipped off with a wire cutter. Screws placed in

these rows will create an intersecting scaffold to

support the distal articular surface.

Figure 11

Anterolateral Plates are available in 4 lengths and in wide and narrow widths.

Wide plates have 3 F.A.S.T. Tabs, while narrow plates have 2 F.A.S.T. Tabs.

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Plates

Medial Tibial Plate

(Cat. No. 8162-1X-0XX).

Similar to the Anterolateral Plate, the Medial Plate

is a low profile, anatomically contoured plate,

designed to fit the medial aspect of the distal tibia.

These thin plates are designed to minimize

discomfort and soft tissue irritation around the

ankle, while still having the strength needed

to achieve rigid fixation of the distal tibial fracture.

All plates come with F.A.S.T. Guides for accurate

drilling and placement of screws, with locking,

lagging, or variable angle screw options available

in the same construct (Figure 12).

In addition, these plates are precontoured and

need little, if any, secondary adjustments to their

shape.

A plate handle can be attached to the distal end

of the plate to facilitate insertion and positioning

of the plate. The distal tab with a non-locking hole

is present to connect distal fragments to the plate.

If this tab is not desired, it can remain unfilled.

Alternatively, it can be easily removed with a

wire cutter.

Figure 12

Medial Plates are available in 4 lengths.

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The proper plate length is selected by ensuring

at least 3-4 screw holes are present proximal to

the most proximal extent of the shaft component

of the fracture.

Application of the Anterolateral Plate

Slide the shaft of the Anterolateral Plate

submuscularly along the lateral border of the tibia,

beneath the anterior compartment muscles and

neurovascular bundle. The optimal position of

the distal plate F.A.S.T. tabs in relation to the joint

is approximately 2 mm from the anterior articular

surface (Figure 13). There should be enough

clearance to permit full dorsiflexion of the ankle.

Use fluoroscopic imaging during plate placement

in both the AP and lateral planes to ensure a safe

implant position proximally along the lateral tibia.

The Plate Handle (Cat. No. 8163-01-003/4) can

be attached to the plate to facilitate insertion and

position the plate in either an open or percutaneous

manner (Figure 14).

The Plate Handle comes in right (Cat. No. 8163-

01-003) and left (Cat. No. 8163-01-004) orientations.

The Plate Handle connects to the distal compression

hole on the shaft of the plate. The Plate Handle is

secured to the plate by tightening the set screw

with the T-15 driver. The plate is provisionally clamped

to the shaft using the Medium Bone/Plate Forceps

(Cat. No. 8163-01-006) proximally (Figure 15).

In most cases the pre-contoured plate will fit without

the need for further bending. The distal tabs may

be contoured as needed using F.A.S.T. Guides and

Plate Tab Benders (Cat. No. 8163-01-001).

To contour the F.A.S.T Tab, place the benders over

a F.A.S.T. Guide in each row and exert pressure

on the distal bender until the desired contour is

achieved (Figure 16).

CAUTION: Bending the distal tabs beyond

25 degrees may result in breakage. Continuous

bending will also fatigue the tab and cause it

to break.

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Figure 13

The optimal position of the

Anterolateral Plate F.A.S.T. Tabs in

relation to the joint is approximately

2 mm from the anterior articular surface.

Figure 14

A Plate Handle can be

used to facilitate plate

insertion and positioning.

Figure 15

Medium Bone/Plate Forceps can be used

to provisionally hold the plate to the bone.

Figure 16

Plate can be shaped using the benders

over the F.A.S.T. Guides.

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Application of the Medial Plate

Slide the Medial Plate proximally under the soft

tissue. The plate conforms to the shape of the

distal tibia and the distal end of the plate should

conform to the shape of the medial malleolus

(Figure 17).

The Plate Handle can be attached to the plate to

facilitate insertion and position the plate in either an

open or percutaneous manner. The Plate Handle

connects to the distal compression hole on the shaft

of the plate. The plate handle is secured to the plate

by tightening the set screw with the T-15 driver.

Provisional Fixation

Once the fit of either the Anterolateral Plate or the

Medial Plate has been confirmed both visually

and fluoroscopically, 1.6 mm K-wires can be placed

into the distal K-wire holes to secure the plate to the

articular block (Figure 18).

A Provisional Fixation Pin (Cat. No. 8242-99-000/1)

may also be used to secure the plate temporarily.

The pin has a self-drilling tip and an AO quick

connection for power insertion. Advance the pin

slowly until the shoulder of the pin contacts the plate

and pulls the plate down to the bone. Advancing

the pin beyond that point could result in the threads

stripping in the bone (Figure 19).

When placing screws in the plate, the plate should

be secured from the distal end to the proximal end

to prevent the plate from “walking” distally.

If the surgeon desires for the distal end of the

plate to sit flush against the bone, then a 4.0 mm

non-locked lag screw should be used. Instructions

on how to insert a 4.0 mm lag screw can be found

in the section titled, “Insertion of a 4.0 mm

Non-Locking Screw”.

Note: If a lag screw is used in the metaphyseal part

of the plate or distal tabs, then that F.A.S.T. Guide

needs to be removed prior to drilling.

Figure 18

Secure plate to the articular block using 1.6 mm K-wires.

Figure 19

A provisional Fixation Pin may also be used to secure the plate temporarily.

Figure 17

Slide the Medial Plate under the soft tissue using Plate Handle.

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Screw Insertion

Insertion of a 3.5 mm Cortical Locking Screw

(Cat. No. 8161-35-0XX) or 4.0 mm Cancellous

Locking Screw (Cat. No. 8161-40-0XX) into

a Distal Threaded Hole.

Slide the Measuring Drill Sleeve (Cat. No. 8163-01-

005) onto the 2.7 mm Calibrated Drill Bit (Cat. No.

2142-27-070) (Figure 20). Drill through the F.A.S.T.

Guide until the far cortex is reached. Slide the

Measuring Drill Sleeve onto the top end of the

F.A.S.T. Guide and read the measurement of the

locking screw length from the proximal end of the

Drill Measuring Sleeve (Figure 21). Next, remove

the F.A.S.T. Guide with the T-15 Driver that is

attached to the Ratchet Handle (8261-66-000) and

insert the pre-determined locking screw using the

T-15 Driver that is attached to the 2.0 Nm Torque-

Limiting Screwdriver Handle (Cat. No. 2141-18-001)

(Figure 22).

Tip: Using a power screwdriver is not

recommended for insertion of any locking screws.

If using power, it should be at a slow speed.

Perform all final screw tightening by hand with

the torque-limiting screwdriver.

Figure 21

Drill through the F.A.S.T. Guide with the 2.7 mm Drill Bit.

Slide the Measuring Drill Sleeve to the top end of the F.A.S.T. Guide and

read the measurement of the Locking Screw length from the proximal end.

Figure 20

Slide the Measuring Drill Sleeve onto the 2.7 mm Calibrated Drill Bit.

24

Figure 22

Insert the pre-determined Locking Screw using the T-15 Driver attached

to Torque Limiting Driver Handle.

39547 Distal 1/11/08 3:06 PM Page 28

25

Screw Insertion

Figure 26

Insert the MDS screw using the 2.2 mm Square Driver

coupled to the Rachet Handle.

Figure 23

MDS Screw allows up to 15 degrees of angulation.

Figure 25

Take a direct reading from the LOCK Line on the Depth Gauge.

Figure 24

Drill with the 2.7 mm Drill Bit through the 2.0/2.7 mm Drill Guide.

Insertion of a 3.5 mm Multi-Directional Locking

Screw in a Threaded Locking Hole

(Cat. No. 8163-35-0XX).

Note: If a 3.5 mm Multi-Directional Screw is used

in the metaphyseal part of the plate or distal tabs,

then that F.A.S.T. Guide needs to be removed

prior to drilling. Additionally, note that the Torque

Limiting Handle should not be used.

Insert the 2.7 mm end of the 2.0/2.7 mm Drill Guide

(Cat. No. 9399-99-435) into the plate hole and angle

the drill as needed within an arc of 15 degrees

(Figure 23). Drill through both cortices with the

2.7 mm Drill Bit (Figure 24).

Measure the drilled hole with the Small Fragment

Depth Gauge (Cat. No. 2142-35-100) by taking a

direct reading from the LOCK line (Figure 25) and

insert the appropriate length 3.5 mm Multi-

Directional Screw with the 2.2 mm Square Driver

(Cat. No. 8163-01-000) coupled to the Ratchet

Handle (Cat. No. 8261-66-000) (Figure 26).

3.5 mm Multi-Directional Screws

39547 Distal 1/11/08 3:06 PM Page 29

26

The proximal end of the plate can now be secured

to the bone. This can be achieved through the

following options:

Insertion of a Locking Screw (3.5 mm Cortical

Cat. No. 8161-35-0XX or 4.0 mm Cancellous

Cat. No. 8161-40-0XX) in a Threaded Hole.

Screw the 2.7 mm Locking Drill Guide (Cat. No.

2142-07-027) into a threaded plate hole until fully

seated. Drill both cortices with the 2.7 mm

Calibrated Drill Bit to the desired depth and read

the depth measurement from the calibrated drill bit

at the top of the drill guide (Figure 27). Remove the

2.7 mm Locking Drill Guide.

Note: If a second method of measurement is

desired, measure the drilled hole by taking a

direct reading from the LOCK line on the Small

Fragment Depth Gauge (Figure 28).

Insert the selected locking screw with the T-15

Driver coupled to the 2.0 Nm Torque-Limiting

Screwdriver Handle (Figure 29).

Figure 27

Drill with the 2.7 mm Calibrated Drill Bit

reading the depth from the top of the Drill Guide.

Screw Insertion

Figure 29

Insert the Locking Screw using the T-15 Driver

coupled to the Torque-Limiting Screwdriver Handle.

Figure 28

Take reading directly from the LOCK Line

on the Small Fragment Depth Gauge.

39547 Distal 1/11/08 3:06 PM Page 30

27

Neutral insertion of a 3.5mm Non-Locking

Cortical Screw (Cat. No. 8150-37-0XX) in a

Compression Slot.

Apply the neutral (green) end of the 2.5 mm

ACP Drill Guide (Cat. No. 8241-68-000) onto

a compression slot in the plate, with the arrow

pointed toward the fracture line (Figure 30).

Drill through both cortices with the 2.5 mm

Drill Bit (Cat. No. 8290-29-070).


Depth Gauge (Figure 31) by taking a direct

reading from the NON-L line.

Insert the 3.5 mm Non-Locking Cortical Screw with

the Screw Holder Sleeve (Cat. No. 8241-66-000) over

the 2.5 mm Hex Driver (Cat. No. 8241-57-071) in the

Ratchet Handle (Cat. No. 8261-66-000) (Figure 32).

Caution: The arrow on the neutral (green) end of

the 2.5 mm ACP drill guide must point toward the

fracture site to ensure neutral screw placement.

Figure 32

Insert the 3.5 mm Non-Locking Cortical Screw using the 2.5 mm Hex Driver.

Screw Insertion

Figure 30

Drill with the 2.5 mm Drill Bit in the neutral position.

Figure 31

Take a depth reading from the NON-L Line.

39547 Distal 1/11/08 3:06 PM Page 31

Screw Insertion

Dynamic compression using a 3.5 mm Non-

Locking Cortical Screw in a Compression Slot.

Apply the compression (gold) end of the 2.5 mm

ACP Drill Guide onto the compression slot with the

arrow pointed toward the fracture line (Figure 33).

Drill through both cortices with the 2.5 mm Drill Bit.


Depth Gauge (Figure 33) by taking a direct reading

from the NON-Line (Figure 34).

Insert the appropriate length 3.5 mm Non-Locking

Cortical Screw with the Screw Holder Sleeve over

the 2.5 mm Hex Driver coupled to the Ratchet

Handle (Figure 35).

28

Figure 33

Drill with the 2.5 mm Drill Bit in the eccentric position.

Figure 35

Insert the 3.5 mm Non-Locking Cortical Screw using the 2.5 mm Hex Driver.

Figure 34

Take the depth reading from the NON-L line.

39547 Distal 1/11/08 3:06 PM Page 32

Figure 36

Drill with the 2.5 mm Drill Bit through the 2.5/3.5 mm Drill Guide.

29

Figure 37


Screw Insertion

Insertion of a 3.5 mm Non-Locking Cortical Screw

in a Threaded Hole.


(Cat. No. 8241-96-000) into the threaded hole and

drill through both cortices with the 2.5 mm Drill Bit

(Figure 36).


Depth Gauge (Figure 37) by taking a direct reading

from the NON-L line.

Insert the appropriate length 3.5 mm Non-Locking

Cortical Screw with the Screw Holder Sleeve over

the 2.5 mm Hex Driver coupled to the Ratchet

Handle (Figure 38).

Figure 38

Insert the 3.5 mm Non-Locking Cortical Screw using the 2.5 mm Hex Driver .

39547 Distal 1/11/08 3:06 PM Page 33

4.0 mm Non-Locking Screw (Cancellous Full

Thread Cat. No. 8153-41-0XX or Cancellous Lag

Cat. No. 8155-40-0XX) into any Plate Hole.


(Cat. No. 2141-29-400) into a plate hole and drill

through both cortices with the 2.9 mm Drill Bit

(Cat. No. 8290-31-070) (Figure 39).


Depth Gauge by taking a direct reading from the

NON-L line (Figure 40).

Insert the appropriate length 4.0 mm cancellous

screw with the screw holder sleeve over the 2.5 mm

Hex Driver coupled to the Ratchet Handle

(Figure 41).

Once completed, a tension free closure is ideal,

using nylon Denoti type stitches for the skin.

Wound closure is performed with the tourniquet

inflated if time permits. If the tourniquet is deflated,

the tissues will swell and the surgeon should wait

several minutes before closing. If tension is evident,

then multiple relaxing incisions may be performed,

or a vacuum assisted closure device can be

applied (V.A.C., Kinetic Concepts, Inc., San

Antonio, TX). Drains are not routinely used. After

closure, the leg is placed in a bulky Jones dressing

with a splint with the ankle in neutral flexion.

Figure 40


30

Figure 39

Drill using 2.9 mm Drill Bit through 2.9/4.0 mm Drill Guide.

Screw Insertion

Figure 41

Insert the 4.0 mm Non-Locking Screw using the 2.5 mm Hex Driver.

39547 Distal 1/11/08 3:06 PM Page 34

31


Anterolateral Distal Tibia Locking Plates:

Orientation Width Holes Length

8162-00-006 Right Wide 6 115 mm

8162-00-009 Right Wide 9 157 mm

8162-00-012 Right Wide 12 199 mm

8162-00-015 Right Wide 15 241 mm

8162-02-006 Right Narrow 6 114 mm

8162-02-009 Right Narrow 9 156 mm

8162-02-012 Right Narrow 12 198 mm

8162-02-015 Right Narrow 15 240 mm

8162-01-006 Left Wide 6 115 mm

8162-01-009 Left Wide 9 157 mm

8162-01-012 Left Wide 12 199 mm

8162-01-015 Left Wide 15 241 mm

8162-03-006 Left Narrow 6 114 mm

8162-03-009 Left Narrow 9 156 mm

8162-03-012 Left Narrow 12 198 mm

8162-03-015 Left Narrow 15 240 mm

Medial Distal Tibia Locking Plates:

Orientation Holes Length

8162-10-006 Right 6 142 mm

8162-10-009 Right 9 184 mm

8162-10-012 Right 12 226 mm

8162-10-015 Right 15 268 mm

8162-11-006 Left 6 142 mm

8162-11-009 Left 9 184 mm

8162-11-012 Left 12 226 mm

8162-11-015 Left 15 268 mm

39547 Distal 1/11/08 3:06 PM Page 35

32


Screws:

3.5 mm Cortical Screws, Locking 8161-35-0XX

10 – 60 mm in 2 mm increments


3.5 mm Multi-Directional Screws, Locking 8163-35-0XX


3.5 mm Cortical Screws, Non-Locking 8150-37-0XX



4.0 mm Cancellous Screws, Full Thread, Locking 8161-40-0XX



4.0 mm Cancellous Screws, Full Thread, Non-locking 8153-41-0XX



4.0 mm Cancellous Screws, Partial Thread, Non-locking 8155-40-0XX



4.0 mm Cannulated Cancellous Screws, Partial Thread, Non-locking 14376-XX



39547 Distal 1/11/08 3:06 PM Page 36


Important:

This Essential Product Information does not include all of the informationnecessary for selection and use of a device. Please see full labeling for allnecessary information.

Indications:

The use of bone plates and screws provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures andreconstructive surgeries. These implants are intended as a guide to normalhealing, and are NOT intended to replace normal body structure or bear theweight of the body in the presence of incomplete bone healing. Delayed unions or nonunions in the presence of load bearing or weight bearing might eventuallycause the implant to break due to metal fatigue. All metal surgical implants aresubjected to repeated stress in use, which can result in metal fatigue.

Contraindications:

• Active infection

• Conditions which tend to retard healing such as blood supply limitations,previous infections, insufficient quantity or quality of bone to permitstabilization of the fracture complex

• Conditions that restrict the patient’s ability or willingness to followpostoperative instructions during the healing process

• Foreign body sensitivity

• Cases where the implant(s) would cross open epiphyseal plates in skeletallyimmature patients

• Cases with malignant primary or metastatic tumors which preclude adequatebone support or screw fixations, unless supplemental fixation or stabilizationmethods are utilized

Warnings and Precautions:

Bone screws and plates are intended for partial weight bearing and non-weightbearing applications. These components cannot be expected to withstand theunsupported stresses of full weight bearing.

Adverse Events:

The following are the most frequent adverse events after fixation with orthopaedicplates and screws: loosening, bending, cracking or fracture of the components or loss of fixation in bone attributable to nonunion, osteoporosis, markedlyunstable comminuted fractures; loss of anatomic position with nonunion ormalunion with rotation or angulation; infection and allergies and adverse reactions to the device material.

.75C01080612-64-506

Printed in USA. ©2008 DePuy Orthopaedics, Inc. All rights reserved.

DePuy International LtdSt Anthony’s RoadLeeds LS11 8DTEnglandTel: +44 (0)113 387 7800Fax: +44 (0)113 387 7890

DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, IN 46581-0988USATel: +1 (800) 366 8143Fax: +1 (574) 371 4865

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